Camera, Surgical and Accessories

FDA 510(k) K934092 · Envision Medical Corp.

Substantially Equivalent

510(k) numberK934092

Submission

Device name
Camera, Surgical and Accessories
Applicant
Envision Medical Corp.
Goleta, CA, US
Received
August 23, 1993
Decision date
January 7, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FWB – Camera, Television, Surgical, Without Audio
Device class
Class I (low risk)
Regulation
21 CFR 878.4160
Specialty
General, Plastic Surgery

Other 510(k)s with product code FWB

510(k)DeviceApplicantDecision
K902359Surgical Video Camera, Model 9500FWB · Traditional Seitz Technical Products, Inc.07/12/1990SE
K884343Sony Color Video Cameras and AccessoriesFWB · Traditional Sony Corp. of America11/01/1988SE
K871057Mc-Series Surgical CamerasFWB · Traditional M.P. Video, Inc.04/03/1987SE
K855020Medical Dynamics CCD Solid State Video Camera 5930FWB · Traditional Medline Industries, Inc.01/24/1986SE
K820829MedicamFWB · Traditional M.P. Video, Inc.05/03/1982SE

More from M.P. Video, Inc.

510(k)DeviceDecision
K9706053-CCD Digital CameraGCJ · Traditional 05/22/1997SE
K953438Surgical Integrated Camera SystemGCJ · Traditional 11/06/1995SE
K951971Xenon Light SourceGCT · Traditional 05/24/1995SE
K944707Isolated Camera HeadFWF · Traditional 10/07/1994SE

Questions and answers

When was Camera, Surgical and Accessories cleared by the FDA?

Camera, Surgical and Accessories (K934092) received a 510(k) decision of Substantially Equivalent on January 7, 1994, 137 days after the submission was received.

What is the product code of K934092?

The FDA product code is FWB – Camera, Television, Surgical, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.